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Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239170
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

Brief Summary:
This is an open-label, single arm, Phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with Gemox in patients with relapsed and refractory hodgkin lymphoma who will receive ASCT.Efficacy will be assessed according to 2014 Lugano criteria.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Camrelizumab(SHR-1210) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-lable, Single Arm, Phase 2 Study of Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Will Receive ASCT
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Camrelizumab(SHR-1210) Combined With GEMOX Drug: Camrelizumab(SHR-1210)
Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin
Other Name: GEMOX(Gemcitabine, Oxaliplatin)




Primary Outcome Measures :
  1. Complete Response [ Time Frame: From first patient first visit to 3 month after last patient first visit ]
    Based on Lugano 2014 criteria


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: From first patient first visit to 3 month after last patient first visit ]
    Rate of subjects achieved complete response plus partial response in all evaluable subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed classic Hodgkin's lymphoma ;
  2. Relapsed or refractory cHL and meet any of the following criterions:a)did not achieve remission or progression and will receive autologous hematopoietic stem cell transplantation.b)receive no more than 3 lines of systemic chemotherapy.
  3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
  4. ECOG performance status of 0 or 1;
  5. Life expectancy ≥ 12 weeks.;
  6. Adequate laboratory parameters during the screening period as evidenced by the following:

    1. Hemoglobin ≥ 90 g/L;
    2. Absolute neutrophil count ≥ 1.5 × 109/L ;
    3. Platelets ≥ 100 × 109/L;
    4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),
    5. ALT and AST ≤ 2.5×ULN
    6. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;
    7. Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
  7. Women of childbearing potential(WOCBP)with pregnancy test negative within 7 days before entering the group and consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment; Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment.
  8. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

  1. Known nodular lymphoma predominant Hodgkin lymphoma
  2. History and complication as follows,

    1. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
    2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group
    3. Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.
    4. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.
    5. Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.
    6. Known and highly Suspicion of interstitial pneumonia.
    7. Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded).
    8. Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1.
    9. Prior allo-HSCT.
    10. Impact of major surgery or severe trauma had been eliminated for less than 28 days
    11. Active pulmonary tuberculosis.
    12. Severe acute or chronic infection requiring systemic therapy.
    13. Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
    14. Suffering from heart failure (New York Heart Association standard III or IV). Uncontrolled coronary artery disease and arrhythmia although given appropriate medical treatment. History of myocardial infarction within 6 months.
    15. Three months before randomization, there were significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, stool occult blood test is ++ at baseline and above, or vasculitis
  3. Laboratory test

    1. Known HIV positive or known AIDS.
    2. Untreated active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.
  4. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.
  5. Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239170


Contacts
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Contact: Yuqin Song, MD (+8610)88196118 SongYQ_VIP@163.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Jun Zhu, MD    (+8610)88196596    Zj@bjcancer.org   
Sponsors and Collaborators
Peking University

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Responsible Party: Jun Zhu, Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine, Peking University
ClinicalTrials.gov Identifier: NCT04239170    
Other Study ID Numbers: SHR-1210-GEMOX-IIT-HL
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs